Novartis Phase III failed to meet primary endpoint

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Novartis announced today that patupilone (EPO906) did not show a significant overall survival advantage in a phase III trial of patients with advanced ovarian cancer, refractory or resistant to platinum-based therapy.

The comparator arm in the trial was Doxil/Caelyx (pegylated liposomal doxorubicin).

Investigators involved in the study and regulatory agencies have been notified of the trial outcome. No new or unexpected serious adverse events in the patupilone arm were identified in the trial. Novartis does not plan to proceed with regulatory filings based on these data.

The Phase III study, conducted in approximately 168 sites in 22 countries, was an open label, active controlled, parallel group, multicenter trial of 829 patients with epithelial ovarian, primary fallopian or primary peritoneal cancer, who were randomized to receive patupilone or Doxil/Caelyx. Before enrollment in the trial, patients had received up to a maximum of three prior chemotherapeutic regimens, of which the first was a taxane/platinum therapy. Patients were randomly assigned to intravenous patupilone (10 mg/m2) once every three weeks or Doxil/Caelyx (50 mg/m2) once every four weeks and were evaluated for disease status by Ca-125 and CT scans every eight weeks until disease progression. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, safety and overall response rate.